Comparison of Different Objective Nociceptive Measurement Methods During Surgery

Sponsor
Göteborg University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218551
Collaborator
(none)
75
1
14.4
5.2

Study Details

Study Description

Brief Summary

Traditionally, hemodynamic response e.g. pulse and blood pressure are used to evaluate pain in humans who are anesthetized. These values, however, can be affected by factors other than pain response . In this observational study, different types of digital methods are used that can distinguish signs of pain. However, the study aim to collect data and correlate in between different methods to ensure its reliability.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In humans who undergoing anesthesia or only receiving sedation with the addition of painkillers medication under surgery. Nociceptive response usually treats on the basis of hemodynamic and/or respiratory changes. These are interpreted together with a number of other parameters. The anesthetist can't be totally sure if it is nociceptive response or to light anesthesia given. Today, there are new monitors included techniques for measuring pain (nociception), but these are not used routinely.

    By put sensors (adhesive patches) on the skin and connect to these new devices perhaps the anesthetist can be more sure what stimuli patient are responding from, pain or light anesthesia.

    These techniques measure muscle activity including sweat gland which have been shown in other research studies demonstrate a higher accuracy regarding the response to nociception. The parameters are presented on a monitor as a value, 0-10 or 0-100. This research study is an observational study and intends to observe values / figures that arise from two different types of commercial monitors and manufactures. After the anesthesia, these values will be compared and evaluated in resect as well to hemodynamic response and in between monitors. The two techniques have never before been studied simultaneously on the same human been (control).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Different Objective Nociceptive Measurement Methods During General Anesthesia or Sedation Under Surgery
    Actual Study Start Date :
    Jan 2, 2022
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Mar 15, 2023

    Outcome Measures

    Primary Outcome Measures

    1. An index will be observed 0-100 and hemodynamic response, heart rate and blood pressure. [numbers will be collected every minute during the surgery often 1 hour]

      Data collect only numbers. These are going to be correlated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients over 18 yrs old,

    • Patients who will be anesthetized or sedated under intervention surgery or surgery

    Exclusion Criteria:
    • Not speaking Swedish

    • Neuro cognitive diorders e.g. dementia or can't respond on information given.

    • Chronic pain

    • Acute brain trauma

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University hospital Gothenburg Sweden 41310

    Sponsors and Collaborators

    • Göteborg University

    Investigators

    • Study Director: Pether Jildenstål, Prof., Göteborg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Göteborg University
    ClinicalTrials.gov Identifier:
    NCT05218551
    Other Study ID Numbers:
    • 2021-03692
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2022